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FDA Creates New Pathway for Emergency Use Authorization of SARS-CoV-2 Serology Tests

NEW YORK – The US Food and Drug Administration has created a new pathway for Emergency Use Authorization of serology tests for SARS-CoV-2.

Dubbed an "umbrella" pathway for serology, it entails submitting tests for evaluation to an interagency testing group, with that evaluation currently being done at the National Cancer Institute, Timothy Stenzel, director of the US Food and Drug Administration's Office of In Vitro Diagnostics and Radiological Health, said during a Wednesday conference call for test developers.

"If performance metrics are met, then those [submitted tests] have a pathway to authorization," Stenzel said.

The pathway is primarily intended for rapid serology tests but could also be applied to ELISAs, he said.

Tests pursuing authorization through this pathway will be run against a panel of samples from at least 30 samples confirmed positive for anti-SARS Cov-2 antibodies for each of the immunoglobulins the test is intended to detect. Stenzel said the pathway is currently limited to tests for IgM and IgG antibodies.

Tests will also be run against 80 confirmed antibody negative samples or pre-COVID-19 samples, with 10 of these 80 negative samples being HIV positive.

Tests reporting on both IgM and IgG must perform with overall sensitivity of 90 percent and specificity of 95 percent. Tests reporting the immunoglobulins separately must have sensitivity for IgM of at least 70 percent and 90 percent for IgG. Additionally, tests must show no cross-reactivity with HIV, which Stenzel said has emerged as a concern with serology testing.

The pathway is currently open to test developers, Stenzel said.

The announcement comes amid mounting questions about the clinical performance and utility about serology tests for detecting antibodies against COVID-19. Earlier in the month, the FDA said it would work with the NCI and National Institute of Allergy and Infectious Diseases to validate coronavirus serology tests.

To date, eight antibody tests for the coronavirus have received EUA from the FDA though dozens more have been launched without such designation under a so-called Policy D pathway that allows makers of such tests to market them without an EUA as long as they have notified the FDA they have validated their tests.